Proposal for a Directive of the European Parliament and of the Council amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury {SEC(2006) 194}
Date: 2006-02-21
Institutions: European Commission
Subjects: consumer protection, dangerous substance, environmental protection, marketing restriction, mercury

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.2.2006 
COM(2006) 69 final 

2006/0018 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 76/769/EEC relating to restrictions on the marketing of 
certain measuring devices containing mercury 

(presented by the Commission) 

{SEC(2006) 194} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

On 28 January 2005 the Commission adopted a communication on the Community 
strategy  concerning  mercury1  underpinned  by  an  Extended  Impact  Assessment 
(ExIA)2.  The  Strategy  considers  the  impacts  of  mercury  on  a  global  basis  and 
proposes measures to protect human health and the environment from the release of 
mercury  based  on  a  life-cycle  analysis  taking  into  account  production,  use,  waste 
treatment and emissions. 

With the aim of reducing the demand for mercury for use in products and to speed up 
the  substitution  of  mercury,  the  ExIA  indicated  that  it  would  be  appropriate  to 
introduce a Community level marketing restriction on mercury-containing measuring 
and  control  equipment  for  consumer  use  and,  with  some  exemptions,  in  the 
healthcare sector. While most control equipment for household use, e.g. thermostats, 
falls within the scope of Directive 2002/95/EC3 (RoHS Directive), measuring devices 
such  as  fever  and  room  thermometers,  barometers,  blood  pressure  gauges  and 
manometers  do  not  depend  on  electric  currents  to  work  properly  and  therefore  fall 
outside of the scope of the RoHS Directive. These non-electrical measuring devices 
are the subject of the present proposal (compare Action 7 of the Strategy). 

The objective of the Directive is to introduce harmonised provisions with regard to 
mercury  by  imposing  restrictions  on  measuring  devices  and  thus,  by  preventing 
considerable amounts of mercury entering the waste stream, to contribute to a high 
level  of  protection  of  the  environment  and  human  health,  whilst  preserving  the 
internal market, as required by Article 95 of the Treaty. 

•  General context  

Mercury  and  its  compounds  are  highly  toxic  to  humans,  ecosystems  and  wildlife. 
Initially  seen  as  an  acute  and  local  problem,  mercury  pollution  is  now  also 
understood to be global, diffuse and chronic. Mercury is persistent and can change in 
the  environment 
to 
methylmercury  occurs  mostly  via  diet.  Methylmercury  collects  and  concentrates  in 
the aquatic food chain in particular, making populations with high intake of fish and 
seafood particularly vulnerable (especially in the coastal areas of the Mediterranean). 
Direct exposure to mercury via inhalation of vapour and absorption through the skin 
is also a health risk.  

into  methylmercury 

form.  Exposure 

the  most 

toxic 

Although  some  mercury  is  released  by  natural  sources,  additional  releases  from 
anthropogenic  sources  like  coal  burning  and  its  use  in  products  have  led  to 
significant increase of concentrations in the environment. It is therefore important to 

1 
2 
3 

COM (2005) 20 final, 28.1.2005 
SEC (2005) 101, 28.1.2005 
Directive 2002/95/EC of 27 January 2003 on the restriction of the use of certain hazard substances in 
electrical and electronic equipment, OJ L 37, 13.2.2003, p. 19 

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reduce  anthropogenic  mercury  releases  to  the  environment  either  through  measures 
relating  to  the  control  of  emissions  or  through  measures  at  earlier  stages  of  the 
mercury cycle such as supply and use. 

Demand for mercury stands at around 3,600 tons per year globally, including around 
300  tons  in  the  EU.  The  main  global  uses,  accounting  for  over  75%,  are  artisanal 
goldmining,  batteries  and  the  chlor-alkali  industry.  Of  these,  only  the  chlor-alkali 
industry  remains  a  significant  user  in  the  EU,  although  the  mercury  cell  process  is 
now being phased out. The next most significant application in the EU is in  dental 
amalgam, which is addressed by Community legislation on medical devices and on 
waste  management.  Among  other  major  product  groups,  Community  legislation 
covers  electrical  and  electronic  equipment  (RoHS  directive).  The  main  mercury 
product group not yet covered by Community law is non-electrical or non-electronic 
measuring and control equipment. 

The information available shows that 80-90% of all mercury used in measuring and 
control devices is used in medical (fever) thermometers and other thermometers for 
household  use.  Although  the  use  of  mercury  is  declining,  the  quantities  remain 
significant;  33  tons  of  mercury  is  estimated  to  be  used  for  measuring  and  control 
devices  per  year  in  the  EU,  and  on  an  annual  basis  some  25-30  tons  of  mercury 
enters the cycle via thermometers alone2.  

The  levels  of  emissions  of  mercury  to  the  environment  have  decreased  as  an 
increasing  share  of  the  equipment  is  collected  and  the  mercury  is  recovered,  but 
nevertheless  emissions  are  still  significant.  RPA  20024  has  suggested  that  the 
emission  to  air  will  be  about  8  tons  per  year  from  a  consumption  of  33  tons  of 
mercury per year in new measuring and control equipment plus 27 tons entering the 
waste  stream  from  old  equipment.  However,  it  is  difficult  to  quantify  the  disposal 
over time as most of this equipment has long service lifetime. Many of the consumer 
products containing mercury will end up being land filled with the potential for slow 
but long term leaching. Some mercury-containing instruments are subject to spills in 
dwellings in the case of breakages.  

From  a  risk  management  perspective  it  is  appropriate  to  distinguish  between 
measuring devices for  consumer use and those for professional uses in science and 
industry. The professional uses are highly specialised. While the mercury content per 
item can be quite high, the numbers are quite limited and this equipment is typically 
used in systems with well established control procedures on safety at work place and 
management  of  dangerous  waste.  In  contrast,  it  has  proved  extremely  difficult  to 
keep  used  measuring  devices  for  consumer  uses  out  of  the  waste  stream.  Some 
Member  States  (e.g.  NL,  FR)  report  that  the  mercury  from  products  is  the  main 
source of mercury in surface water. 

Results from a study by RPA from 2002 indicate that most measuring equipment for 
consumers (around two thirds) is now imported into the EU. Many thermometers and 
other measuring equipment are imported from China, India and Japan. Within the EU 
there  are  major  manufactures  in  the  UK  and  Germany  (RPA  2002).  Europe  is  the 

4 

RPA (2002). Risk to health and the environment related to the use of mercury products. Report by Risk 
and Policy Analysts Ltd for DG Enterprise of the European Commission 

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principal manufacturing area for instruments for technical or scientific applications, 
the other main source being the Far East.  

For  the  measuring  devices  used  by  private  households,  substitutes  are  available  at 
similar prices and in fact the substitution process is already fairly well advanced. The 
available studies and information from industry show that for specialist industrial and 
scientific measuring devices the situation  is far less clear cut. In quite a number of 
cases, adequate substitutes are not available, or have considerably higher costs.  

•  Existing provisions in the area of the proposal 

Various  mercury  containing  products  have  been  already  banned  or  restricted  in  a 
number  of  countries  such  as  Denmark,  France,  the  Netherlands  and  Sweden. 
Although the scope of the restrictions varies, most of the specialist professional uses 
are excluded from the scope of this national legislation in almost all cases. 

•  Consistency with other policies and objectives of the Union  

This  action  would  be  in  line  with  legislation  for  this  substance  used  in  other 
applications such as electrical and electronic equipment. It would also contribute to 
implementing the Water Framework Directive which considers mercury as one of the 
priority hazardous substances. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

All  the  interested  parties  have  been  consulted  through  a  very  wide  consultation 
process  in  the  course  of  preparing  the  Mercury  Strategy.  In  the  course  of  the 
consultation  the  Commission  has  organised  meetings  with  Member  States  and 
stakeholders and has launched an open public consultation on the internet where the 
specific issue of whether the EU should take additional action to limit the marketing 
of  measuring  and  control  equipment  was  addressed.  Overall,  there  was  strong 
support for EU action; further details can be found in the ExIA.  

In addition, as a part of consultation exercise on 2 May 2005, DG ENTR circulated a 
preliminary  draft  of  the  proposal  to  all  interested  parties  (Member  States,  industry 
representatives, NGOs). This draft was presented during the meeting of the Working 
Party under the Directive 76/769/EEC (Limitations Directive)5 on 20 May 2005. The 
meeting  provided  an  opportunity  for  stakeholders  to  give  initial  reactions  to  the 
consultation  document;  in  general  there  was  strong  support  for  the  proposal.  All 
Member  States  who  took  the  floor  favoured  the  proposal.  Some  of  them  asked  the 
Commission  to  widen  the  scope  of  restrictions  and  to  include  at  least  the  blood 
pressure devices used in the healthcare sector (with the exemption of strain-gauges). 
They  also  urged  the  Commission  in  the  short  term  to  continue  to  work  towards  a 

5 

OJ L 262, 27.9.1976, p. 201 

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phase  out  of  mercury  containing  products  within  the  scope  of  the  Limitations 
Directive, and not to rely on the authorisation procedure in REACH6. 

Member  States  were  asked  to  provide  feedback  to  the  analysis  presented.  In 
particular, if Member States requested a widening of the scope of the restriction, they 
were asked to supply the technical, scientific and economic information necessary to 
justify the restriction and to demonstrate the proportionality. Subsequently 5 replies 
were  received.  Four  Member  States  requested  widening  the  scope  to  include 
sphygmomanometers  used  in  the  healthcare  sector  whereas  one  had  the  opposite 
opinion. 

referred 

the  question  of  a  potential 

The  Commission 
restriction  on 
sphygmomanometers  used  in  healthcare  sector  to  the  Member  State  experts  on 
medical  devices.  This  consultation  concluded  that  hospitals  need  a  high  level  of 
accuracy  to  treat  life-threatening  conditions  such  as  hypertension,  arrhythmia  and 
pre-eclampsia.  Mercury  sphygmomanometers  provide  the  appropriate  level  of 
accuracy  and  reliability  to  maintain  patient's  safety.  The  same  level  of  reliability  is 
not yet achievable by alternative blood pressure monitors.  

Whereas mercury sphygmomanometers will be needed for the foreseeable future for 
testing  and  calibrating  other  blood  pressure  manometers,  the  position  should  be 
reviewed 
that  non-mercury 
sphygmomanometers  are  suitable  not  only  for  the  measurement  of  blood  pressure 
trends, but also for the diagnosis and treatment of hypertension and for clinical trials. 

if  and  when  evidence  becomes  available 

A group of four NGOs said the proposal should be expanded to include all consumer 
and professional uses. 

Opposition  to  the  proposal  was  expressed  by  the  European  Medical  Devices 
Association and by two manufacturers of barometers.  

Further  details  on  comments  received  are  included  in  the  accompanying  Impact 
Assessment [SEC(2006) 194 of 21.2.2006]. 

•  Impact assessment 

Measuring equipment is the largest mercury-using product group in EU not covered 
by Community legislation on mercury. For this product group two main options were 
examined: the “no additional action” option and the “marketing and use restrictions” 
option.  The  latter  option  would  prohibit  the  marketing  of  measuring  and  control 
devices  by  means  of  an  amendment  to  the  Directive  76/769/EEC.  The  scope  of  a 
limitation  under 
the  feasibility  and 
proportionality of the risk management measure proposed. The information available 
to  the  Commission  can  be  considered  as  sufficient  to  support  a  ban  on  all  fever 
thermometers and other measuring devices for consumer uses. Specialist applications 
are  excluded  from  the  scope  of  this  proposal.  Adequate  substitutes  are  not  always 

that  directive  must 

into  account 

take 

6 

Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, 
Evaluation Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals 
Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}, 
COM (2003) 644 final, 29.10.2003 

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available, and most specialist professional uses are outside the scope of most national 
legislation. The costs and benefits for this option are briefly presented below: 

–  Costs 

The  economic  impact  of  the  proposed  restriction  is  expected  to  be  small.  For 
measuring  devices  used  by  private  households  substitutes  are  available  at  similar 
prices. According to the information available, the number of remaining producers in 
the EU is limited to a small number of enterprises. This is also illustrated by the fact 
that  no  sectoral  organisation  exists  on  a  European  or  Member  State  level.  The 
negative  impact  on  the  producers  has  to  be  balanced  against  the  avoided  costs  of 
removing  mercury  in  waste  management  and  of  dealing  with  the  impacts  of 
emissions.  The  measure  can  be  therefore  regarded  as  cost  efficient  by  comparison 
with some other measures already in place (e.g. restriction of mercury in batteries or 
in lighting). 

The  expected  social  impact  from  the  proposed  restriction  is  largely  limited  to 
potential  job  losses  with  the  producers  that  cannot  switch  to  the  production  of 
substitutes.  The  comments  received  in  the  consultation  process  indicate  that  the 
negative effects on employment would be very limited.  

The  impact  will  be  neutral  as  far  as  trade  is  concerned.  Some  external  suppliers 
would  lose  a  market  for  their  products  although  at  the  same  time  any  external 
suppliers manufacturing mercury-free substitutes would find their market expanded.  

–  Benefits 

The  main  benefit  of  a  restriction  on  the  marketing  of  certain  measuring  devices 
would be a reduction of mercury in the municipal waste stream. There would also be 
benefits  to  the  healthcare  waste  stream.  The  overall  result  would  be  to  have  more 
effective  waste  management  and  a  reduction  of  emissions  from  landfill  and 
incineration. 

The key long term benefit of reducing mercury emissions will be decreased levels of 
mercury  in  the  environment.  This,  in  turn,  will  lead  to  lower  levels  of  human 
exposure to mercury including methylmercury in fish with resultant health benefits. 
The measure will also reduce the impacts of mercury in soils and on biodiversity. 

A reduction in the use of mercury containing measuring devices in households will, 
in  addition,  avoid  mercury  spills  in  dwellings.  Although  such  spills  rarely  have  a 
direct effect on human health they are a source of exposure and of emissions which 
should be minimised. 

In  view  of  the  global  and  transboundary  nature  of  the  environmental  and  health 
impacts of mercury, this proposal would also support EU initiatives at international 
level to promote a global of reduction of mercury use. 

Further details on the options examined and the results of the economic, social and 
environmental  impacts  of  the  proposal  are  included  in  the  accompanying  Impact 
Assessment [SEC(2006) 194 of 21.2.2006].  

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3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The objective of the present proposal is to provide a high level of protection of the 
environment and human health, whilst preserving the internal market, as required by 
Article 95 of the Treaty. It does so by introducing harmonised provisions with regard 
to mercury to restrict its use in measuring devices, and thereby preventing significant 
amounts of mercury entering the waste stream. 

•  Legal basis 

The proposal is an amendment to Directive 76/769/EEC relating to restrictions on the 
marketing and use of dangerous substances and preparations for which the legal basis 
is Article 95 of the Treaty.  

In  compliance  with  Article  95  of  the  Treaty,  the  proposal  is  submitted  to  the 
European  Parliament  and  Council  under  the  co-decision  procedure.  The  European 
Economic and Social Committee is also consulted. 

•  Subsidiarity principle 

All Member States that expressed an opinion have supported Community restrictions 
on  mercury  at  a  discussion  in  the  Working  Group  for  implementation  of  Directive 
76/769EEC,  as  well  as  in  responses  to  the  Commission  consultation  document  on 
mercury.  Furthermore  it  is  not  appropriate  to  address  this  issue  by  way  of  targets; 
such  an  approval  would  result  in  diverse  measures  at  Member  State  level  with 
resulting distortions in the internal market and less effective health and environment 
safeguards overall. Establishing a restriction on certain measuring devices containing 
mercury  at  Community  level  would  have  a  higher  effectiveness  than  leaving  such 
measures  to  the  Member  States  alone.  The  proposed  directive  would  establish 
uniform rules for the circulation of products within the internal market. The measure 
proposed also contributes to a high level of protection of health and the environment. 
In  summary  the  proposed  amendment  to  Directive 76/769/EEC  is  the  only  way  to 
fully meet these goals. 

•  Proportionality principle 

The  relatively  large  amounts  of  mercury  which  are  still  used  for  the  production  of 
measuring devices, and the high risks associated with those uses justify Community 
action  in  this  area.  The  restrictions  on  fever  thermometers  and  other  measuring 
devices  intended  for  consumer  use  cover  the  major  part  of  mercury  use  and 
emissions  from  this  product  group.  The  remaining  specialised  uses  in  science  and 
industry either lack reliable alternatives or they  are very expensive.  Restrictions on 
this product group would not be proportionate. In addition, systems are in place for 
the  collection  and  recovery  of  the  mercury  discarded  from  this  category.  Such  an 
approach is a technically and economically appropriate measure to exclude mercury 
from  the  municipal  waste  stream  as  the  sources  are  quite  limited  in  number.  The 
proposed directive would yield benefits in terms of protecting human health and the 
environment as part of the overall risk management measures on this substance. This 
will be achieved at comparatively little cost. 

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•  Choice of instrument 

The proposed instrument is a directive amending Directive 76/769/EEC. 

4. 

BUDGETARY IMPLICATIONS 

There are no budgetary implications from the proposed Directive. 

5. 

ADDITIONAL INFORMATION 

The present directive restricts the placing on the market of new measuring devices. 
This restriction does not apply to devices that are already in use, or which are sold 
second hand. The short term aim is to reduce the amount of mercury released to the 
environment. As the amount of mercury in existing household equipment is greater 
than the amount represented by sales of new equipment, the Commission intends to 
undertake  a  further  separate  study  (reference  Action  10  of  the  Strategy)  to  address 
this issue. 

In  the  medium  to  longer  term,  any  remaining  use  is  likely  to  be  subject  to 
authorisation under the proposed REACH Regulation (see Action 8 of the Strategy). 

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2006/0018 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directive 76/769/EEC relating to restrictions on the marketing of 
certain measuring devices containing mercury 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 95 thereof, 

Having regard to the proposal from the Commission7 

Having regard to the opinion of the European Economic and Social Committee8, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty9, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

 The  Commission  communication  of  28  January  2005  on  the  Community  strategy 
concerning mercury10, which considered all uses of mercury, concluded that it would 
be  appropriate  to  introduce  Community-level  marketing  restrictions  on  certain  non-
electrical or electronic measuring and control equipment containing mercury, which is 
the main mercury product group not covered by Community action so far. 

 There would be benefits for the environment, and in long term for human health, by 
preventing mercury from entering the waste stream, if limitations on the marketing of 
measuring devices containing mercury were introduced. 

 Taking into account technical and economic feasibility, available evidence concerning 
measuring  and  control  devices  indicates  that  restrictive  measures  should  cover  only 
those measuring devices intended for sale to the general public and in one area of the 
healthcare sector. 

 By  the  present  Directive  only  the  placing  on  the  market  of  new  measuring  devices 
should  be  restricted.  This  restriction  should  therefore  not  apply  to  devices  that  are 
already in use, or sold second hand. 

7 
8 
9 
10 

OJ C xxx 
OJ C xxx 
OJ C xxx 
COM (2005) 20 final, 28.1.2005 

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(5) 

(6) 

(7) 

 The  disparities  between  the  laws  or  administrative  measures  adopted  by  Member 
States  as  regards  restriction  on  mercury  in  various  measuring  and  control  devices 
could create barriers to trade, distort competition in the Community and may thereby 
have  a  direct  impact  on  the  establishment  and  functioning  of  the  internal  market.  It 
therefore appears necessary to approximate the laws of Member States in the field of 
measuring  and  control  devices  by  introducing  harmonised  provisions  with  regard  to 
those products containing mercury thus preserving the internal market whilst ensuring 
a high level of protection of human health and the environment.  

 Council  Directive  76/769/EEC11  of  27  July  1976  on  the  approximation  of  the  laws, 
regulations and administrative provisions of the Member States relating to restrictions 
on the marketing and use of certain dangerous substances and preparations should be 
amended accordingly. 

 This Directive should apply without prejudice to Community legislation laying down 
in  Council 
minimum  requirements  for 
Directive 89/391/EEC12 of 12 June 1989 on the introduction of measures to encourage 
improvements  in  the  safety  and  health  of  workers  at  work  and  individual  directives 
based  thereon,  in  particular  Council  Directive 98/24/EC13  of  7  April  1998  on  the 
protection of workers from the risks related to chemical agents at work.  

the  protection  of  workers  contained 

HAVE ADOPTED THIS DIRECTIVE: 

Annex I to Directive 76/769/EEC is amended as set out in the Annex to this Directive. 

Article 1 

Article 2 

1. 

Member States shall adopt and publish, by xx xx 200x [one year after the date of its 
entry  into  force]  at  the  latest,  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive.  They  shall  forthwith  communicate  to  the 
Commission  the  text  of  those  provisions  and  a  correlation  table  between  those 
provisions and this Directive. 

They shall apply those provisions from xx xx 200x [eighteen months after the entry 
into force of this Directive]. 

When Member States adopt those provisions, the provisions shall contain a reference 
to  this  Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their 
official  publication.  Member  States  shall  determine  how  such  reference  is  to  be 
made. 

11 

12 

13 

OJ  L  262,  27.9.1976,  p.  201  Directive  as  last  amended  by  Commission  Directive  2004/98/EC 
(OJ L 305, 1.10.2004, p. 63) 
OJ  L 183, 29.6.1989, p. 1. Directive  as  amended  by  Regulation  (EC) No 1882/2003  of  the  European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) 
OJ L 131, 5.5.1998, p. 11-23. 

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2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the day of its publication in the Official Journal of the 
European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX 

The following point 19a is inserted in Annex I of Directive 76/769/EEC: 

“19a 
Mercury 
CAS N° 7439-97-6 

May not be placed on the market: 
(1) in fever thermometers 
(2) in  other  measuring  devices  intended  for  sale  to  the  general 
public  (e.g.  manometers,  barometers,  sphygmomanometers, 
thermometers other than fever thermometers). ” 

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